Tinea PedisPhase 2NCT01891305
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
A Phase 2 study testing VT-1161 in people with Tinea Pedis, run by Viamet at 7 sites in United States.
Trial summary
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- VT-1161
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male and non-pregnant female patients ≥18 years and <65 years
- Clinical diagnosis of tinea pedis
- Positive baseline KOH
- Clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)
- Patients must be able to swallow capsules intact
- Use acceptable birth control methods
Who cannot join
- Major organ system disease or clinical infection
- Poorly controlled diabetes mellitus
- Pregnant or lactating
- Confluent, diffuse moccasin-type tinea pedis
- Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail
- Recent use of topical corticosteroids, topical antibiotics, or topical antifungal therapy to the foot
Show all 9Show fewer
- Recent use of systemic corticosteroids or antifungal therapy
- Known(HIV)infection
- Known significant hepatic, or hematologic impairment .Requirement for treatment with concomitant antimicrobial or systemic antifungal therapy for any reason.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Univ Alabama at Birmingham
Birmingham, Alabama, 35233
J&S Studies, Inc.
College Station, Texas, 77845
Florida Academic Dermatology Center
Miami, Florida, 33136
FXM Research
Miramar, Florida, 33027
Pariser Dermatology Specialists
Norfolk, Virginia, 23507
Oregon Dermatology & Research Center
Portland, Oregon, 97210
Wake Research Associates
Raleigh, North Carolina, 27612
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Moderate to Severe Interdigital Tinea Pedis
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. A safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable.
- Conditions
- Tinea Pedis
- Being tested
- VT-1161, placebo
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-1161Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| VT-1161 200/50mg | Experimental | Not described Receives: Drug: VT-1161 |
| VT-1161 600/150mg | Experimental | Not described Receives: Drug: VT-1161 |
| VT-1161 1200/300mg | Experimental | Not described Receives: Drug: VT-1161 |
| Matching placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viamet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891305
- Sponsor's protocol ID
- VMT-VT-1161-CL-003
- Status last verified
- Jul 2018
- First submitted
- 17 Jun 2013
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Moderate to Severe Interdigital Tinea Pedis
- ClinicalTrials.gov ID
- NCT01891305
- Acronym / sponsor ID
- VMT-VT-1161-CL-003
- Conditions
- Tinea Pedis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ViametIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Posted 6 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. A safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VT-1161 200/50mg | Experimental | Drug: VT-1161 |
| VT-1161 600/150mg | Experimental | Drug: VT-1161 |
| VT-1161 1200/300mg | Experimental | Drug: VT-1161 |
| Matching placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male and non-pregnant female patients ≥18 years and <65 years
- Clinical diagnosis of tinea pedis
- Positive baseline KOH
- Clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)
- Patients must be able to swallow capsules intact
Key exclusion criteria (9 listed)
- Major organ system disease or clinical infection
- Poorly controlled diabetes mellitus
- Pregnant or lactating
- Confluent, diffuse moccasin-type tinea pedis
- Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VT-1161 | Drug | VT-1161 1200/300mg, VT-1161 200/50mg, VT-1161 600/150mg |
| placebo | Drug | Matching placebo |
Primary outcome
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
Time frame: 6 weeks
For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tinea Pedis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VT-1161 in people with Tinea Pedis, run by Viamet at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.